Deep Brain Stimulation for the Treatment of Alzheimer's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01559220|
Recruitment Status : Completed
First Posted : March 21, 2012
Last Update Posted : March 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Device: Deep Brain Stimulation||Not Applicable|
Open label pilot study
- Expected direct benefit on the modulation of neuronal networks.
- Expected indirect benefit via potential enhancements of memory, executive functions, cognition behavioral control, and functional abilities.
Up to 10 subjects will be implanted with bilateral DBS systems, participants are expected to be on study for about 23 months.
- Develop a multidisciplinary clinical research protocol to evaluate the efficacy of ventral striatum, nucleus accumbens, and internal capsule for the amelioration of disability caused by Alzheimer's Disease.
- Enroll up to 10 patients into an open label study to evaluate the safety and efficacy of DBS for Alzheimer's Disease patients with mild to moderate disability.
- Determine an initial DBS titration and stimulation settings protocol for use in subsequent controlled trials.
- Evaluate the outcomes of this study based on clinical, laboratory, biomarker, imaging, cognitive, behavioral, and functional assessments.
- Determine what domains of cognitive, behavioral and functioning impairment show the greatest response to DBS.
- Examine the potential benefit of stimulation combined with behavioral and rehabilitation interventions in comparison to stimulation alone.
- Evaluate the influence of DBS on physiological and functional changes in cortical and subcortical networks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Deep Brain Stimulation (DBS) for Treatment of the Cognitive, Behavioral, and Functional Disability of Alzheimer's Disease|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: Open Label
DBS Implant and stimulation
Device: Deep Brain Stimulation
Other Name: Deep Brain Stimulation Device
- Clinical Dementia Rating Scale [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559220
|United States, Ohio|
|Wexner Medical Center at the Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Ali Rezai, MD||Ohio State University|